myCSG © |Area: SDTM| Concept: IS : Immunogenicity Specimen Assessments | Lesson: LADAB : SDTM IS dataset - ADAB - Anti-Drug Antibodies |

 

Background
  • The immune system protects the body from pathogenic microorganisms and other allergenic toxic substances by producing antibodies.
  • In some clinical trials, we may have to collect data about immune response of the body. 
  • Some example data points are:
    • Antidrug antibodies
    • Hepatitis C Virus Antibody
    • Antibodies against SARSCOV2
  • SDTM standard has a standard domain for capturing these findings - "Immunogenicity Specimen Assessments (IS)"
  • IS dataset belongs to Findings class and has an expected record structure of 'One record per test per visit per subject'

What type of information is typically collected or presented?
  • Date of assessment
  • Test performed status
    • Yes
    • No 
      • Reason not performed
  • Short name of the test
  • Name of the test
  • Result
    • in original units
    • in standard units
  • Normal ranges
    • lower limit
    • upper limit
  • Type of the specimen
  • Method of assessment
  • Derived information
    • Baseline flag - when results of a test are collected over pre and post treatment period
 
  • Complete key programming for SDTM IS dataset:
  • This lesson uses antidrug antibody titer value
  • Involves creation of testcd and result variables
  • Derivation of --LOBXFL, SEQ, study day etc.

ISADA : Anti-Drug Antibodies
Question Response
Date Collected
[ISDAT_RAW]
Titer Value
[ISTITER]



SUPPVARIABLE_NAMEVARIABLE_LABELTYPEGENERAL_COMMENTFORM_SMWT
_ STUDYID Study Identifier Char Populate as 'statschoice'
_ DOMAIN Domain Abbreviation Char Populate as 'IS'
_ USUBJID Unique Subject Identifier Char Concatenate the value of STUDYID variable to SUBJECT variable with a hyphen in between.
_ ISSEQ Sequence Number Num Sort the records by USUBJID, ISCAT, ISTESTCD, ISDTC and set to 1 on the first record for each subject, and increment by 1 for each subsequent record within the subject
_ ISTESTCD Immunogenicity Test/Exam Short Name Char Create a record with ISTESTCD=ADA to store the result from ISTITER.
_ ISTEST Immunogenicity Test or Examination Name Char Populate as 'Antidrug Antibody' when ISTESTCD=ADA.
_ ISORRES Results or Findings in Original Units Char Populate using ISTITER when creating row for FTTESTCD=ADA.
_ ISORRESU Original Units Char Populate as "Titer"
_ ISSTRESC Character Result/Finding in Std Format Char Populate with the values from IS.ISORRES
_ ISSTRESN Numeric Results/Findings in Std. Units Num Popuate with the values from IS.ISSTRESC after converting to numeric format where applicable.
_ ISSTRESU Standard Units Char Populate as "Titer"
_ ISSPEC Specimen Type Char Populate as "SERUM"
_ ISMETHOD Method of Test or Examination Char Populate as "ELECTROCHEMILUMINESCENCE IMMUNOASSAY"
_ ISLOBXFL Last Observation Before Exposure Flag Char Populate as "Y" on the latest record with non-missing result on or prior to DM.RFXSTDTC for each subject and test.
_ VISITNUM Visit Number Num Populate with the value from FOLDERSEQ
_ VISIT Visit Name Char Populate with the value from FOLDERNAME
_ ISDY Study Day of Visit/Collection/Exam Num Populate using IS.ISDTC and DM.RFSTDTC. If ISDTC is on or after RFSTDTC then populate with the resulting value of ISDTC-RFSTDTC+1. Else if ISDTC is before RFSTDTC then populate with the resulting value of ISDTC-RFSTDTC.
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